Clinical Trial: Immunogenicity and Safety of 3-Dose and Booster Dose of Tetravalent Dengue Vaccine in Healthy Subjects 9 to 50 Years of Age

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Immunogenicity and Safety of Tetravalent Dengue Vaccine Given in 1 , 2 , or 3 Dose Schedules (STAGE I) Followed by a Single Booster Injection of the Same Vaccine (STAGE II) 1 or 2 Years After the Last

Brief Summary:

The aim of the study is to assess the safety of the primary series vaccine schedules and the booster vaccination

Primary Objectives:

  • To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by tetravalent CYD vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post-final vaccination.
  • To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by tetravalent CYD vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post final vaccination.
  • To demonstrate the non-inferiority of the immune response elicited against each dengue serotype 28 days after administration of a single booster dose of tetravalent CYD vaccine

Secondary Objectives:

  • To demonstrate the superiority of the immune response elicited by tetravalent CYD vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post-final vaccination.
  • To demonstrate the superiority of the immune response elicited by tetravalent CYD vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post-final vaccinati

    Detailed Summary: Healthy subjects between age 9 and 50 year will receive in various schedules of CYD vaccine and placebo administration over a 12-month period. They will be further randomized to receive a single booster vaccination of CYD vaccine at either 12 months or 24 months following the last primary series injection.
    Sponsor: Sanofi Pasteur, a Sanofi Company

    Current Primary Outcome:

    • Summary of Neutralizing antibody titers against each dengue virus serotype 28 days after the last CYD dengue vaccine injection in each Group primary series schedules [ Time Frame: 28 days after the last CYD dengue vaccine ]
      Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).
    • Summary of Neutralizing antibody titers against each dengue virus serotype 28 days post booster dose (Year 1 and Year 2, respectively, for each group tested in STAGE II) [ Time Frame: 28 days after the booster vaccination ]
      Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Number of subjects with seroconversion 28 days after injection for each of the 4 parental dengue virus strains of CYD dengue vaccine [ Time Frame: 28 Days post each vaccination ]
      Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT). Seroconversion is percentage of subjects with either a pre booster titer < 10 (1/dil) and a post booster titer ≥ 40 (1/dil), or a pre booster titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post booster titer
    • Summary of neutralizing antibody titers against each dengue virus serotype immediately prior to booster dose and post booster in all 3 CYD vaccination groups [ Time Frame: 28 days after the booster vaccination ]
      Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).
    • Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial [ Time Frame: Day 0 up to 2 years post vaccination ]
      Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia


    Original Secondary Outcome: Same as current

    Information By: Sanofi

    Dates:
    Date Received: December 9, 2015
    Date Started: May 2016
    Date Completion: July 2020
    Last Updated: September 22, 2016
    Last Verified: September 2016